Inspection, measuring, and test equipment form a significant part of the quality-system foundation for successful medical device manufacturers. Device manufacturers need effective tools to gage adherence to approved product specifications; and the vehicle employed for doing so is the performance of acceptance activities utilizing inspection, measuring, and test equipment.
In this week’s edition of Devine Guidance , Dr. D will complete (it’s about time!) the review of section 820.70 of the Quality System Regulation (QSR), and focus on subsection (h) manufacturing material, and (i) automated processes.
In this week’s edition of Devine Guidance (DG), Dr. D will continue down the production and process controls path by examining the requirements for subsections (f) buildings, and (g) equipment. Buildings and equipment fall into Dr. D’s not rocket science category.
As promised, in the week’s edition of Devine Guidance (DG) Dr. D will continue with analyzing the requirements associated with 21 CFR, Part 820 – Section 820.70; subsections (c) environmental control, (d) personnel, and (e) contamination control.
The Quality System Regulation (QSR), for production and process controls, (21 CFR, Part 820 – Subpart G, Section 820.70) is in the opinion of Dr. D one of the more salient requirements of the regulation.
The identification and traceability (sections 820.60 and 820.65) for products and finished medical devices, throughout the entire manufacturing process, including raw materials employed during the manufacturing process, and the subsequent sale and distribution of medical devices, are critical elements of the Quality System Regulation (QSR).
FDA is really taking medical device manufacturers to task in regards to purchasing controls and the overall management of their suppliers. According to Kimberly Trautman, FDA’s current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) expert, suppliers providing non-conforming material are directly related to an increase in medical device recalls; which increases the need for effective quality processes to mitigate risk. As the medical device industry continues to grow in leaps and…
The control of documentation is one the fundamental cornerstones supporting the foundation needed for an effective quality system, whether compliance is to EN ISO 13485, EN ISO 9000, the Medical Device Directive, or in the case of this series of Devine Guidance articles, the Quality System Regulation (QSR).
In this fourth and final foray into Subpart C – Design Controls, Dr. D will review the last three subsections; (h) design transfer, (i) design changes, and (j) the design history file (DHF), located within section 820.30. These final three elements of design control are just as important as the previous subsections dissected as part of Devine Guidance.
The proverbial rubber meets the road when the actual execution of test protocols commences. In this edition of Devine Guidance , Dr. D will continue with his dissection of 21 CFR, Part 820; Section 820.30, subsection f (design verification) and subsection g (design validation).
